Clinical Operations Manager

Title: Clinical Operations Manager
Location: Bridgewater, NJ
Duration: 6 months consulting (renewable contract)

Hours per week: 37.5

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Under minimal supervision, individual designs, supervises and develops clinical trial strategies.
Prepares and facilitates the review of case report forms, protocols, investigators brochures, instructions for use, study operations manuals, site and FDA annual reports.
Develops and maintains relationships with outside consultants and vendors as required for each protocol.
Reviews and approves study budgets within the established guidelines, provides initial review of study contracts for changes.
Estimates product needs with management approval, initiates supply management process.
Assists in preparation of regulatory submissions to FDA.
Serves on cross-functional teams and interfaces internally with marketing, regulatory affairs, health economics and reimbursement and research project teams to provide technical consultation as appropriate. Interfaces externally with clinical investigators, investigational sites and project vendors.
Anticipates, recognizes and resolves issues that many have impact on compliance or project deliverables.
Prepares, organizes and presents at Investigators Meetings and other internal and external meetings.
Develops and contributes to internal and external training and communication programs.
Mentors junior staff to enhance understanding of the clinical study processes and study conduct.
Assists with site visits (eg co-monitoring).
Creates and manages timelines for milestone deliverables.
Reviews proposals, contracts and budgets along with consultation of study manager.
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

EDUCATION and/or EXPERIENCE: BS or equivalent and 5 9 years of clinical research experience; or MS and 3 7 years; or Ph.D. and 0 4 years; or equivalent combination of education and/or experience.

OTHER SKILLS and ABILITIES: Proficiency in current computer programs required. Excellent written and oral English communication skills required. Multi-tasking, understanding of regulatory processes (FDA/ICH-GCP), and Project Management skills essential. Approximately 30% travel (on average) required.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

Required Skills:
--See job description--df-tc

Experience/Skills
See Above

Other desired skills:
Clinical Operations Manager